[Federal Register Volume 65, Number 64 (Monday, April 3, 2000)]
[Proposed Rules]
[Pages 17455-17458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-8123]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 65, No. 64 / Monday, April 3, 2000 / Proposed
Rules
[[Page 17455]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 93
[Docket No. 99-054-1]
Spanish Pure Breed Horses from Spain
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations that govern the
importation of Spanish Pure Breed horses from Spain, a country in which
contagious equine metritis, a venereal disease of horses, may exist. We
would allow Spanish Pure Breed horses to be imported from Spain into
the United States under the same conditions that apply to thoroughbred
horses from certain other regions in which contagious equine metritis
either exists or may exist. We are proposing this action because
Spanish Pure Breed horses, like thoroughbred horses from those other
regions, are less likely to be infected with contagious equine metritis
than other horses, largely because the life history and medical records
of each horse is known and can be certified by a veterinarian of the
national government of the region of origin. This action would relieve
some restrictions on the importation of Spanish Pure Breed horses into
the United States.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by June 2, 2000.
ADDRESSES: Please send your comment and three copies to:
Docket No. 99-054-1, Regulatory Analysis and Development, PPD,
APHIS, Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Please state that your comment refers to Docket No. 99-054-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Morley Cook, Senior Staff
Veterinarian, Animals Program, National Center for Import and Export,
VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301)
734-6479.
SUPPLEMENTARY INFORMATION:
Background
The animal importation regulations (contained in 9 CFR part 93 and
referred to below as the regulations), among other things, prohibit or
restrict the importation of certain animals, including horses, into the
United States to protect U. S. livestock from communicable diseases,
including contagious equine metritis (CEM). CEM is a contagious
venereal disease of horses and other equidae that affects breeding and
fertility.
To prevent the introduction of CEM, Sec. 93.301(c)(1) lists regions
in which CEM exists or in which CEM may exist because those regions
have traded horses freely with regions in which CEM exists without
testing for CEM. These regions are referred to below as listed regions.
Paragraph (c)(1) prohibits the importation of horses into the United
States from listed regions unless the horses are imported in accordance
with certain requirements. The horses must be:
Wild species of equidae if captured in the wild or
imported from a zoo or other facility where it would be unlikely
that the animal would come in contact with domesticated horses used
for breeding;
Geldings;
Weanlings or yearlings;
Horses imported in specific cases under conditions
prescribed by the Administrator of APHIS as provided in
Sec. 93.301(a);
Thoroughbred horses imported for permanent entry from
France, Germany, Ireland, or the United Kingdom as provided in
Sec. 93.301(d);
Stallions or mares over 731 days of age for permanent
entry as provided in Sec. 93.301(e) (which requires pre-export
testing, Federal quarantine upon arrival, and post-entry quarantine
in a State approved to receive horses from listed regions);
Horses over 731 days of age imported for no more than
90 days to compete in specified events as provided in
Sec. 93.301(f); or
U.S. horses returning to the United States as provided
in Sec. 93.301(g).
The Equine Breeding Service of the Spanish Government has requested
that we amend the regulations to allow Spanish Pure Breed horses to be
imported into the United States from Spain under the same conditions
that apply to thoroughbred horses from France, Germany, Ireland, and
the United Kingdom. Currently, Spanish Pure Breed horses other than
weanlings and yearlings may be imported for permanent entry into the
United States only in accordance with Sec. 93.301(e). France, Germany,
Ireland, and the United Kingdom are listed regions, as is Spain.
However, the requirements in Sec. 93.301(d) for importing thoroughbred
horses from France, Germany, Ireland, and the United Kingdom are less
restrictive than the requirements in Sec. 93.301(e) because the life
history and medical records of each thoroughbred horse imported from
these countries is known and can be certified by a veterinarian of the
national government of the region of origin.
Under Sec. 93.301(d), each thoroughbred horse from France, Germany,
Ireland, and the United Kingdom must be accompanied at the time of
importation by an import permit and an import health certificate. The
requirements related to import permits are contained in Sec. 93.304 of
the regulations. The requirements related to import health certificates
are contained in Sec. 93.314 of the regulations.
According to Sec. 93.314, an import health certificate must be
issued by a salaried veterinary officer of the national government of
the region of origin, and it must certify that each horse has been in
that region for the 60 days preceding exportation; that each horse has
been inspected on the premises of origin and has been found free of
evidence of communicable disease, and exposure to communicable disease,
during the 60 days preceeding exportation; and that each horse has not
[[Page 17456]]
been vaccinated with a live, attenuated, or inactivated vaccine for the
14 days preceding exportation, unless authorized by the Administrator
of APHIS.
Paragraph (d) of Sec. 93.301 requires that the veterinarian signing
and issuing the import health certificate also certify that he or she
has examined the daily records of the horse's activities maintained by
the trainer and the records of the horse's activities maintained by a
breed association that is specifically approved by the U.S. Department
of Agriculture. The veterinarian must certify that the information in
these records is consistent and current.
For thoroughbred horses over 731 days of age, the import health
certificate must also certify that cultures negative for CEM have been
obtained from sets of specimens collected from each horse on 3 separate
occasions within a 7-day period. The last set of specimens must have
been collected within 30 days of exportation. All specimens must have
been received within 48 hours of collection by a laboratory approved to
culture for CEM by the national veterinary service of the region of
export. All specimens must have been accompanied by a statement
indicating the time and date of their collection.
Under Sec. 93.301(d), if any specimen is found positive for CEM,
the horse it was collected from must be treated for CEM in a manner
approved by the national veterinary service of the region of export.
After the treatment is completed, at least 21 days must pass before the
horse is eligible to be tested again.
Additionally, Sec. 93.301(d) requires that thoroughbred horses
imported from France, Germany, Ireland, and the United Kingdom complete
the Federal quarantine required under Sec. 93.308 before they can be
released in the United States. Thoroughbred horses that were found
positive for, and were treated for, CEM in the region of export must be
further quarantined under State or Federal supervision until they have
met the additional testing and treatment requirements in
Sec. 93.301(e)(3) for stallions or Sec. 93.301(e)(5) for mares.
Under Sec. 93.301(e)(3), specimens must be collected from each
stallion's prepuce, urethral sinus, and fossa glandis, including the
diverticulum of the fossa glandis, and must be cultured for CEM. If the
results are negative, the stallion must be test bred to two mares,
after which the stallion must undergo the following treatment for 5
consecutive days: the prepuce, the penis, including the fossa glandis,
and the unrethral sinus of the stallion must be thoroughly cleaned and
scrubbed with a solution of not less than 2 percent surgical scrub
chlorhexidine, while the stallion is in full erection, and then
thoroughly coated with an ointment effective against the CEM organism.
Cultures must be made from sets of specimens collected from the
mucosal surfaces of the clitoral fossa and clitoral sinuses of each
test mare on the third, sixth, and ninth days after test breeding. A
complement fixation test for CEM must be performed on each test mare on
the fifteenth day after the test breeding. If the result of any culture
taken from either of the test mares or from the stallion is positive
for CEM, the stallion must undergo the treatment described above and
then be test bred again to two mares no sooner than 21 days after the
last day of the treatment. Treatment and test breeding must be repeated
until all tests are negative for CEM.
Under Sec. 93.301(e)(5), sets of specimens must be taken from mares
on days 1, 4, and 7 of a 7-day period. The specimens must be taken from
the mucosal surfaces of the clitoral fossa and the clitoral sinuses and
cultures must be made. After the three sets of specimens have been
taken, organic debris must be manually removed from the clitoral
sinuses of each mare and the sinuses must be flushed with a cerumalytic
agent. For 5 consecutive days after the sinuses of the mare have been
cleaned, the external genitalia and vaginal vestibule, including the
clitoral fossa, must be aseptically cleaned and washed with a solution
of not less than 2 percent chlorhexidine in a detergent base, and then
the clitoral fossa and the clitoral sinuses must be filled and the
external genitalia and vaginal vestibule must be coated with an
antibiotic ointment effective against the CEM organism. All test
results must be negative for CEM before the mare may be released from
quarantine. If any test is positive, the mare must be treated again and
then tested no less than 21 days after the last day of the treatment
described above. Treatment and testing must be repeated until all tests
are negative for CEM.
All specimen collections, test breeding, and treatments required
under Sec. 93.301(e)(3) and Sec. 93.301(e)(5) must be performed by an
accredited veterinarian. All specimens must be submitted to the
National Veterinary Services Laboratories, Ames, IA, or to a laboratory
approved by the Administrator to conduct CEM cultures and tests. All
test results must be negative for CEM before the horses may be released
from quarantine.
These conditions ensure that thoroughbred horses imported into the
United States from France, Germany, Ireland, and the United Kingdom are
free of CEM.
At the request of the Equine Breeding Service of the Spanish
Government, we are proposing to allow Spanish Pure Breed horses to be
imported from Spain into the United States under the same conditions
that apply to thoroughbred horses from France, Germany, Ireland, and
the United Kingdom. We would add the Servicio de Cria Caballar y
Remonta as the breed association that is specifically approved by the
U.S. Department of Agriculture for the purposes of Sec. 93.301(d).
The Spanish Pure Breed horse is only one of seven or eight breeds
of purebred horses originating in Spain, but current and accurate
historical and medical information is not readily available for the
other breeds, so they are not included in this proposed rule. This
action would relieve some restrictions on the importation of Spanish
Pure Breed horses from Spain (i.e., the horses would not have to
undergo the testing and treatment requirements in Sec. 93.301(e)(3) and
Sec. 93.301(e)(5) unless they were found positive for, and were treated
for, CEM prior to exportation).
We have conducted a risk assessment for this proposed rule to
ensure that this action would pose a negligible risk of introducing CEM
into the United States. The risk assessment contains a qualitative
analysis of 11 risk factors, which are listed in 9 CFR part 92,
``Importation of Animals and Animal Products: Procedures for Requesting
Recognition of Regions,'' and a quantitative analysis that evaluates
the frequency with which a Spanish Pure Breed horse infected with CEM
might be imported from Spain into the United States if this proposed
rule were adopted.
According to the qualitative analysis of the risk assessment, Spain
is likely to be free of CEM. Additionally, Spanish veterinary
authorities have the capabilities needed to culture and diagnose CEM.
Routine breeding soundness examinations and investigations of
reproductive diseases and reproductive failures conducted by the
Spanish Government and military veterinarians would detect CEM if it
were to occur in Spanish Pure Breed horses. There has never been a
reported case of CEM in Spain. However, even if CEM were introduced
into Spain, there is very little chance that it would affect the
Spanish Pure Breed population since Spain does not import Spanish Pure
Breed horses and Spanish Pure Breed horses are not bred with other
breeds.
[[Page 17457]]
The quantitative analysis evaluates the number of Spanish Pure
Breed horses that are likely to be imported from Spain, the probability
that a randomly selected horse would be infected with CEM, and the
probability that the infection would be detected by the testing
required under this proposed rule.
According to the quantitative analysis, the predicted average
frequency, with a 95 percent confidence level, with which a Spanish
Pure Breed horse infected with CEM would be released into the United
States is once every 700 years or less often. With a 50 percent
confidence level, the predicted average frequency is one release every
2,300 years or less often.
Thus, based on the risk assessment, we have determined that this
action would pose a negligible risk of introducing CEM into the United
States.
The complete risk assessment for this proposed rule may be obtained
by contacting the person listed under FOR FURTHER INFORMATION CONTACT.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
This proposed rule would allow Spanish Pure Breed horses to be
imported from Spain into the United States under the same conditions
that apply to thoroughbred horses from France, Germany, Ireland, and
the United Kingdom. We are considering this action in response to a
request we have received from Spain's Equine Breeding Service to
relieve some of the restrictions on the importation of Spanish Pure
Breed horses from Spain since the life histories and medical records of
these horses can be certified by Spanish Government veterinarians.
The following analysis addresses the economic effect the proposed
rule would have on small entities, as required by the Regulatory
Flexibility Act.
In 1997, there were 375,218 farms in the United States keeping
2,427,277 horses of all kinds. Approximately 79,516 farms sold 325,306
horses, receiving $1.03 billion in sale revenues. Approximately 98
percent of the farms that sold horses have less than $500,000 in annual
revenue and, therefore, are considered small entities by the U.S. Small
Business Administration.
U.S. importers and breeders of Spanish Pure Breed horses would be
affected by this rule. This rule would make it less expensive for
importers to import Spanish Pure Breed horses from Spain.
There are approximately 270 domestic breeders of Spanish Pure Breed
horses in the United States, most of which are likely to be small
entities. In 1998, there were approximately 2,500 Spanish Pure Breed
horses in the United States and only 225 foals were registered that
year.
In 1995 and 1996, 4 horses (not all of which were Spanish Pure
Breed horses) were imported into the United States from Spain; there
were 21 horses in 1997, 39 in 1998, and 46 in 1999. If the proposed
rule is adopted, we estimate that the number of Spanish Pure Breed
horses imported into the United States from Spain will most likely
increase to an average of about 60 per year, for the next 3 to 5 years,
with a maximum of 100 in any given year.
Currently, the demand for Spanish Pure Breed horses in the United
States is greater than can be supplied by domestic breeders and the
small number of these horses imported from Costa Rica, Mexico, and
Spain. In 1997, 225 Spanish Pure Breed foals were registered in the
United States, while a total of 50 were imported into the United States
from all over the world, despite the high costs of shipping
(approximately $5000 per horse for air freight plus insurance against
mortality, figured at 1 percent of the horse's declared value),
quarantine, and testing. Because domestic Spanish Pure Breed horses are
less expensive than imports, the demand for domestic Spanish Pure Breed
horses would not decrease as a result of this rule. This rule would
help satisfy the growing demand for the horses in the United States,
and make it less expensive for U.S. breeders and importers to obtain
them from Spain.
We do not expect domestic breeders of Spanish Pure Breed horses to
be affected by this rule if it is adopted, since the demand in the
United States for Spanish Pure Breed horses is greater than the
domestic supply and since domestic Spanish Pure Breed horses will still
be less expensive than imported ones.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 99-054-1.
Please send a copy of your comments to: (1) Docket No. 99-054-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,
OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW.,
Washington, DC 20250. A comment to OMB is best assured of having its
full effect if OMB receives it within 30 days of publication of this
proposed rule.
This proposed rule may increase the number of import permits and
import health certificates that will be issued for the importation of
thoroughbred horses into the United States.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average .78947 hours per response.
[[Page 17458]]
Respondents: Salaried veterinary officers of the Spanish Government
and U.S. importers of Spanish Pure Breed horses.
Estimated annual number of respondents: 15.
Estimated annual number of responses per respondent: 6.333.
Estimated annual number of responses: 95.
Estimated total annual burden on respondents: 75 hours.
(Due to rounding, the total annual burden may not equal the product
of the annual responses multiplied by the average reporting burden per
response.)
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue, SW., Washington, DC 20250.
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, we propose to amend part 93 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105, 11,
114a, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.2(d).
Sec. 93.301 [Amended]
2. In Sec. 93.301, footnote 6 would be amended by adding the words
``Servicio de Cria Caballar y Remonta for Spain;'' immediately after
the word ``Department:''.
3. In Sec. 93.301, paragraph (c)(2)(v), the heading to paragraph
(d), and the introductory text in paragraph (d)(1) would be revised to
read as follows:
Sec. 93.301 General prohibitions; exceptions.
* * * * *
(c) * * *
(2) * * *
(v) Spanish Pure Breed horses imported for permanent entry from
Spain or thoroughbred horses imported for permanent entry from France,
Germany, Ireland, or the United Kingdom if the horses meet the
requirements of paragraph (d) of this section;
* * * * *
(d) Spanish Pure Breed horses from Spain and thoroughbred horses
from France, Germany, Ireland, and the United Kingdom. (1) Spanish Pure
Breed horses from Spain and thoroughbred horses from France, Germany,
Ireland, and the United Kingdom may be imported for permanent entry if
the horses meet the following requirements:
* * * * *
4. In Sec. 93.301, in paragraph (d)(1)(ii)(D), the first sentence,
the words ``For thoroughbred horses'' would be removed and the words
``For Spanish Pure Breed horses and thoroughbred horses'' would be
added in their place.
5. In Sec. 93.301, in paragraph (d)(3), the words ``Thoroughbred
horses'' would be removed and the words ``Spanish Pure Breed horses and
thoroughbred horses'' would be added in their place each time they
appear.
Done in Washington, DC, this 28th day of March 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-8123 Filed 3-31-00; 8:45 am]
BILLING CODE 3410-34-U